FDA Recall
OngoingHistorical recordClass II
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44
by MACLEODS PHARMA USA, INC
- Reason
- Presence of foreign substance: plastic-like substance.
- Published
- May 22, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 29, 2025Historical recordClass II
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04
by Lupin Pharmaceuticals Inc.
- Reason
- Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
- Published
- May 22, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 29, 2025Historical recordClass II
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04
by Lupin Pharmaceuticals Inc.
- Reason
- Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
- Published
- May 22, 2024
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass II
Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01
by Dercher Enterprises, Inc., DBA Gordon Laboratories
- Reason
- cGMP Deviations
- Published
- May 22, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: June 25, 2024Historical recordClass I
Infinite Herbs, LLC
- Product
- Infinite Herbs Organic Basil packed in a clear 2.5 oz, 2.0 o…
- Reason
- Salmonella typhimurium in organic basil
- Published
- May 22, 2024
- Distribution
- Florida, Illinois, Missouri, Virginia, C…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: March 10, 2025Historical recordClass II
M-C McLANE INTERNATIONAL
- Product
- Jalapenos packed in 6lb 10oz cans. 6 cans per case
- Reason
- Glass contamination
- Published
- May 22, 2024
- Distribution
- Alabama, Arizona, California, Colorado,…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: June 20, 2024Historical recordClass III
East West Tea Company, LLC
- Product
- Organic Yogi Echinacea Immune Support, Caffeine Herbal Suppl…
- Reason
- Organic Yogi Echinacea Immune Support product is recalled because pesticide residues were detected above action levels.
- Published
- May 22, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Out of specification for assay
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
by Aurobindo Pharma USA Inc.
- Reason
- Discoloration: Dotted and yellow spots on tablets
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
by Aurobindo Pharma USA Inc.
- Reason
- Discoloration: Dotted and yellow spots on tablets
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 22, 2025Historical recordClass III
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06
by Acella Pharmaceuticals, LLC
- Reason
- Subpotent drug
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 9, 2024Historical recordClass II
TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762
by RemedyRePack Inc.
- Reason
- Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00
by Rubicon Research Private Limited
- Reason
- Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass I
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Sub-potent Drug; powder discoloration associated with decreased potency
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass I
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Sub-potent Drug; powder discoloration associated with decreased potency
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 16, 2024Historical recordClass I
Belgian Yummies
- Product
- Belgian Yummies Homemade Ice Cream Horchata Gelato. Package…
- Reason
- Undeclared Allergen: milk and wheat.
- Published
- May 15, 2024
- Distribution
- The products were only distributed in th…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 16, 2024Historical recordClass I
Belgian Yummies
- Product
- Salted Caramel Ice Cream Cookie Sandwich. Sandwiches package…
- Reason
- Undeclared Allergen: milk, eggs, soy, wheat, peanuts, and tree nuts.
- Published
- May 15, 2024
- Distribution
- The products were only distributed in th…
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Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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